Unique ID issued by UMIN | UMIN000015104 |
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Receipt number | R000017580 |
Scientific Title | Prospective intervention study of novel SGLT-2 inhibitor ipragliflozin in patients with type 2 diabetes |
Date of disclosure of the study information | 2014/09/10 |
Last modified on | 2017/12/25 17:46:32 |
Prospective intervention study of novel SGLT-2 inhibitor ipragliflozin in patients with type 2 diabetes
Prospective intervention study of novel SGLT-2 inhibitor ipragliflozin in patients with type 2 diabetes
Prospective intervention study of novel SGLT-2 inhibitor ipragliflozin in patients with type 2 diabetes
Prospective intervention study of novel SGLT-2 inhibitor ipragliflozin in patients with type 2 diabetes
Japan |
Type 2 diabetes
Endocrinology and Metabolism |
Others
NO
To investigate the efficacy and safety of ipragliflozin under clinical use condition, and investigate suitable patients who can be administrated ipragliflozin using stratified analysis by BMI before administration and duration of disease
Safety,Efficacy
Change and percent change in HbA1c from baseline to 52 weeks
Change and percent change in following items from baseline to 12, 24, and 52 weeks
1) HbA1c (Except for the change at 52 week)
2) fasting plasma glucose, insulin, HOMA-beta, HOMA-R
3) body weight and waist circumference
4) Serum lipid (TC, LDL-C, TG, HLD-C)
5) Blood pressure
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Orally administration of 50 mg ipragliflozin once a day, pre or post breakfast for 52 weeks
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1) Aged from 20 to 80 years at providing consent
2) With poorly controlled patients who undergoes diet/exercise therapy or hypoglycemic agent at least 12 weeks
3) HbA1c >= 6.5 and < 9.5%
4) BMI >= 20kg/m2
5) Provide written informed consent
1) Type 1 diabetes
2) With severe ketosis, diabetic coma, or precoma within 6 months
3) With severe infection, pre or post surgery, and serious trauma
4) With moderate or severe renal dysfunction (Serum Creatinine male: >= 1.5mg/dL, female: >= 1.3mg/dL)
5) Has stroke, myocardial infarction, or other serious cardiovascular complications requireing hospitalization within 6 months
6) Is receiving SGLT-2 inhibitor at initiation
7) Is nursing or pregnant or planned to become pregnant
8) Has hypersensitivity to ipragliflozin or any other excipient of ipragliflozin
9) Considered as inadequate by the investigator
100
1st name | |
Middle name | |
Last name | Hiroaki Seino |
Seino Naika Clinic
Medical director
6-192-2, Kaisei, Koriyama-city, Fukushima, Japan
024-983-1024
kn7jh5@bma.biglobe.ne.jp
1st name | |
Middle name | |
Last name | Hiroaki Seino |
Seino Naika Clinic
Medical director
6-192-2, Kaisei, Koriyama-city, Fukushima, Japan
024-983-1024
kn7jh5@bma.biglobe.ne.jp
Seino Naika Clinic
Astellas Pharma Inc.
Profit organization
NO
2014 | Year | 09 | Month | 10 | Day |
Partially published
Completed
2014 | Year | 09 | Month | 13 | Day |
2014 | Year | 09 | Month | 17 | Day |
2014 | Year | 09 | Month | 10 | Day |
2017 | Year | 12 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017580
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